The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars

Full Thickness Skin Defects Clinical Trial

Official title: A Phase 1, Randomized, Multicentre Multinational Study to Evaluate the Safety and Feasibility of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects in Human Patients.

Status Completed

Clinical Trial Summary

In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.

Clinical Trial Description

Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated. ;

Related Conditions & MeSH terms

• Full Thickness Skin Defects

• NCT number: NCT02164760
• Study type: Interventional
• Source: Association of Dutch Burn Centres
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Completion date: June 2016